Janssen Pharmaceutical has reported new long-term data from the VOYAGE 1 clinical trial’s open-label phase, evaluating tremfya for the treatment of adults with moderate to severe plaque psoriasis.
Data showed well-maintained skin clearance rates experienced by patients treated with tremfya were sustained at week 52 and week 156.
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Tremfya is a subcutaneous, anti-interleukin (IL)-23 monoclonal antibody. It secured approvals in multiple countries, including the US, Canada and Japan.
VOYAGE 1 is a randomised, double-blind, placebo and active comparator-controlled Phase III trial, conducted to compare the efficacy and safety of tremfya with placebo and adalimumab.
Participants received placebo at weeks zero, four and 12, and were then subjected to tremfya crossover at weeks 16 and 20.
Some patients were randomised for 100mg tremfya at weeks zero, four and 12, or 80mg adalimumab at week zero and 40mg at week one, with crossover to tremfya at week 52.
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By GlobalDataAt week 156, 82.1% of the combined group of subjects achieved ‘cleared or minimal disease’ status.
Responses based on the Psoriasis Symptoms and Signs Diary (PSSD), which assesses patient-reported symptoms, were also observed to be consistent at week 100 and week 156.
Of the 494 patients in this group, 86.2% reported adverse events (AEs) at week 156, while 13.4% had serious AEs, 67.8% experienced infections and 2.2% had serious infections.
Trial investigators did not find any cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions in the investigational drug arm.
Janssen Research & Development immunology head Newman Yeilding said: “The data adds to the growing body of safety and efficacy evidence with the use of tremfya over a three-year period.
“As a part of our commitment to developing innovative therapies for chronic, immune-mediated disease like psoriasis, we have been focusing on generating long-term data so that patients and physicians can be more informed when making treatment decisions.”
The new results were presented at the 37th Fall Clinical Dermatology Conference in Las Vegas, Nevada.
